Kornimate/medical-research-clean huggingface dataset:
medtronic psr tdd pmcf

Conditions: Chronic Pain; Spasticity, Muscle

Summary: the purpose of this study is to provide continuing evaluation and reporting of safety and performance of the synchromed ii infusion system within its intended use. data will support post-market surveillance obligations.

this study was originally posted under nct01524276 and now posted alone to adapt to new iso regulation.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has or is intended to receive or be treated with an eligible medtronic product * patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment * the indication for implant meets approved indications * the patient can reasonably be expected to remain fully on label for a 48-month time period after implant exclusion criteria: * patient who is, or will be, inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results * there is no indication at enrollment (e.g., medical conditions, anticipated relocation, etc.) that the patient will be unable to complete 48 months of follow-up after implant
biobank carcinoma: storing blood and protein of patients with cancer

Conditions: Cancer

Summary: the purpose of this study is to determine, by means of dna and protein analysis, the relationship between dna and protein profiles and a number of endpoints, which are important for the patient such as overall survival and side effects.

it has already been known for a long time that cancer is a genetic disorder and that the development of the illness is a very complex interaction between genetic and surrounding factors. also the response on therapy and the development and seriousness of side effects is stipulated by this complicated collaboration of genetic and surrounding factors. moreover it is not only the dna that plays an important role but also the systems of control at protein level. at this moment a lot of questions remain to be answered because up till now the studies were of rather restricted statistic strength with frequently inconsistent dates and moreover retrospective. major retrospective studies are necessary to distinguish the relationship between dna/protein patterns and clinical relevant endpoints like prognosis and toxicity in which an as broad as possible patient group is being monitored. for this reason we want to take blood samples in maastro clinic of all patients with lung cancer and to store it encrypted so that we can perform dna and protein analyses in future and to correlate the results with survival and toxicity of the treatment.

Eligibility criteria:
inclusion criteria: * cancer exclusion criteria: * not able to comply with follow-up

Keywords: cancer genomics proteomics
maintaining nonsmoking: older smokers - 1

Conditions: Tobacco Use Disorder

Summary: the purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.

the overall goals of this line of research were to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. the specific aims of the current study were to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, older smokers and the interaction of these interventions with gender and depression. participants were 50 years or older and smoker 10 or more cigarettes per day. baseline assessments includes measures of smoking behavior, nicotine dependence, depression diagnosis, demographics and life circumstances and measures of anger, depression and mood disturbance, stress, social support, health status, motivation for changed and drug and alcohol use.

Eligibility criteria:
smokers of at least 10 cigarettes per day inclusion criteria: multiple exclusion criteria: multiple

Keywords: smoking cessation tobacco
safety and tolerability of multiple dose lersivirine for 21 days in healthy subjects

Conditions: Healthy Volunteers

Summary: randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed phase 3 formulation) given over 21 days, compared to lersivirine 500 mg qd (phase 2b formulation). the pharmacokinetics of lersivirine in each group will also be evaluated.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. * use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Keywords: lersivirine uk-453 061 safety tolerability pharmacokinetics hiv non-nucleoside reverse transcriptase inhibitor nnrti
a prediction model for chronic ankle instability

Conditions: Chronic Ankle Instability

Summary: chronic ankle instability is a common problem that may follow an ankle sprain. until a patient has developed chronic ankle instability they are ineligible for surgical treatment although early surgical treatment yields better results compared to surgical treatment of subjects that have experienced recurrent ankle sprains. however, treating all patients with an ankle sprain surgically is not an option due to the high amount of unnecessary invasive interventions. the objective of this study is to identify which patients will develop chronic ankle instability and to develop a model to predict which patients should receive early surgical treatment. in this prospective observational cohort all patients (older than 18 years) that report at the emergency department of the participating hospitals after a lateral ankle sprain, of whom an x-ray is made after positive ottawa ankle rules and on which there is no visible fracture or other pathology. the main study parameter is a significant difference in patient characteristics, foot and ankle configuration and joint pathology between patients who develop chronic ankle instability and patients who do not experience recurrent ankle sprains and restriction during daily live after an initial sprain.


Eligibility criteria:
inclusion criteria: * at least 16 years old * visited the er within one week after a lateral ankle sprain * an anteroposterior and lateral x-ray have been made * agreed with being approached for this study * questionnaires have been returned within 4 weeks * reported lateral ankle pain after an ankle sprain or ankle distortion ankle exclusion criteria: * present fracture or other joint pathology/bone matrix pathology * a diagnosed osteochondral defect after primary inclusion * medial ankle instability * previous ankle surgery * an unreliable x-ray due to the angle in which it is made or low quality * acute surgical repair of the anterior talofibular ligament and/or calcaneofibular ligament or another form of surgery within 6 months after the initial ankle sprain

Keywords: ankle instability prediction
eliquis regulatory post marketing surveillance (rpms)

Conditions: Venous Thromboembolism

Summary: the objective of this regulatory post-marketing surveillance in korea is to reconfirm the clinical usefulness of eliquis through collecting, reviewing, identifying and verifying the safety and effectiveness information about eliquis in general practice


Eligibility criteria:
inclusion criteria: * signed data release * patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty exclusion criteria: * being treated for an indication not approved for the use of eliquis® in korea * is contraindicated for the use of eliquis® as described in the korean label
resistance to hiv infection

Conditions: HIV Infections

Summary: the immune systems of some individuals may be capable of resisting hiv infection. these individuals do not appear to be infected with hiv despite multiple sexual encounters with hiv infected partners. this study will examine the immune systems of these individuals to determine what factors are responsible for their ability to resist hiv infection. study hypothesis: some long-term, multiply-exposed seronegative persons have relative resistance to hiv infection maintained by t cell responses.

rare individuals appear naturally resistant to overt hiv-1 infection despite repeated sexual exposures. these individuals, referred to as exposed seronegatives (es), represent a unique population in which to evaluate mechanisms by which hiv-1 replication is either controlled or aborted. the purpose of the study is to analyze hiv-specific immune responses, both cellular and humoral, that exist in seronegative individuals who have experienced multiple exposures to hiv by sexual contact. this study will follow participants for 2 years. participants will have 25 study visits during the study. assessments will include hiv tests, viral load measurements, cd4 counts, pregnancy tests, and physical exams.

Eligibility criteria:
inclusion criteria: * good general health * hiv uninfected * repeated exposures to hiv through unprotected sexual intercourse within the 2 years prior to study entry * live in the greater seattle area * plan to stay in the greater seattle area for the 2 years after study entry exclusion criteria: * pregnancy

Keywords: hiv seronegativity
clipless laparoscopic cholecystectomy using harmonic scalpel versus conventional method in day surgery

Conditions: Cholelithiasis

Summary: the aim of this study was to compare between the safety and efficacy of the harmonic shears and the commonly used clip technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy in day surgery setting


Eligibility criteria:
inclusion criteria: * symptomatic cholelithiasis * age under 65 yr old * bmi under 35 * asa i or ii exclusion criteria: * acute cholecystitis * suspect of common bile duct stones
multiparametric imaging in multiple myeloma

Conditions: Multiple Myeloma

Summary: patients with multiple myeloma will undergo single timepoint positron emission tomography imaging with intravenously injected c11 methionine to detect viable lesions.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma with symptomatic bone or soft tissue disease * eastern cooperative oncology group status 0 to 2 * life expectance \>= 12 weeks * ability to understand and willingness to sign informed consent * tissue sampling with genotype data planned within 3 months of c11 positron emission tomography (pet) imaging exclusion criteria: * pregnant or breast feeding * claustrophobic reactions and unable to lie still on a bed inside the pet scanner for 60 minutes * research related radiation exposure exceeding 50 millisieverts
prostvac®-vf/tricom™ vaccine for the treatment of metastatic prostate cancer after failing hormone therapy

Conditions: Prostate Cancer

Summary: prostvac-vf is an investigational cancer vaccine. the vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. these targets are called tumor associated antigens, or taa's. this trial will help determine if this vaccine can help fight cancer. this multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of prostvac-vf/tricom co-administered with gm-csf versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (aipc). all patients will be required to sign an informed consent prior to the performance of any on-study procedures. patients will be screened for eligibility within 14 days prior to vaccine administration. patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment. the ratio of active treatment to empty vector control (placebo) is 2:1.


Eligibility criteria:
* male patients \> 18 years of age who have been vaccinated against smallpox; * histological confirmation of adenocarcinoma of the prostate with evidence of metastatic disease including either of the following: lymph node metastasis measurable by ct and/or bone metastasis evaluable by bone scan; * despite hormone therapy, there is evidence of two consecutive increases in psa (prostate specific antigen); * gleason score of 7 or lower at initial diagnosis. please note that there are additional eligibility criteria that you must meet to qualify. if you do qualify to participate, study personnel will explain the trial in detail and answer any questions you may have. you can then decide whether or not you wish to participate. if you do not qualify for the trial, study personnel will explain the reasons.
tissue, blood and biomarkers to predict future atrial fibrillation

Conditions: Atrial Fibrillation

Summary: patients undergoing coronary artery bypass grafting (cabg), aortic (valve) or mitral valve surgery are at risk of developing postoperative and new-onset atrial fibrillation (af), but adequate risk prediction is currently impossible. this study aims to discover tissue and circulating micrornas and protein biomarkers that may help to unravel the pathophysiological processes underlying af and are potential tools for risk stratification and prognosis or may become future targets of therapy. this study will be a single-center cohort study of 150 patients undergoing cardiac surgery, which will constitute the beginning of the follow-up period. left atrial appendages, whole blood and epicardial mappings will be collected. patients will be followed for 2 years with regular holter investigations to detect postoperative and new-onset af.

study procedures: the left atrial appendage (laa) will be removed for research and intended prophylactic purposes, using a surgical stapler or surgical knife prior to the standard procedure. epicardial mappings may be performed during cardiac surgery with a 48-multi-electrode. patients will be followed with regular 24-hour holter investigations. this study will be an exploratory study with a required inclusion of 150 patients, based on the estimated event rate. patients will be recruited by the investigators during pre-operative assessment. clinical data will be gathered at baseline and stored in a customized microsoft access entry database. statistical analysis will be performed in collaboration with the bioinformatics laboratory from the academic medical center.

Eligibility criteria:
inclusion criteria: * elective sternotomy for either coronary artery bypass surgery or aortic (valve) surgery or mitral valve surgery * cha2ds2 vasc score ≥ 2 * sinus rhythm * age between 18 and 80 years * legally competent and willing and able to sign informed consent exclusion criteria: * unable or unwilling to comply with study procedures * documented or reported history of atrial fibrillation, atrial flutter (duration \> 5 minutes) or ventricular tachycardia * emergency or redo of cabg * emergency valvular surgery or pericarditis or endocarditis * nyha class iv heart failure symptoms or left ventricular ejection fraction \< 35% * pregnancy or of childbearing potential without adequate contraception * history of previous radiation therapy of the thorax * active malignancy * active inflammtion or auto-immune disease * surgery for congenital anomalies * circumstances that prevent follow-up (no permanent home or address, transient, etc.)

Keywords: microrna biomarker
the recover sub-study, which leverages quantitative and credible research tools from verily, will provide assessment measures for depressive episodes

Conditions: Treatment Resistant Depression

Summary: the objective of this study is to collect both active and passive data using a wearable, multi-sensor device (verily study watch) and phone application (mood app) which aims to capture mental health status, in subjects participating in the recover clinical trial (a prospective, multi-center, randomized controlled blinded trial demonstrating the safety and effectiveness of vns therapy® system as adjunctive therapy versus a no stimulation control in subjects with treatment-resistant depression).

a prospective, observational, exploratory study collecting passive and active behavioral, environmental and physiological data, via the use of an android smartphone application and study watch. this sub-study is only open to sites participating in the recover clinical study. all subjects participating in the recover clinical trial at active uncover sites will be offered participation in this sub-study. subjects who opt-in to the mood app portion of the sub-study will be followed for a minimum of 12 months and a maximum of 60 months for the mood app portion of the sub-study. subjects who opt-in to the use of the study watch portion of the sub-study will be followed for a minimum of 12 months and maximum of 24 months for the study watch portion of the sub-study.

Eligibility criteria:
inclusion criteria: all subjects 1. current consented subject in the recover clinical trial; 2. adult (i.e. ≥ 18 years of age, unless a resident of any u.s. state where the age of majority is 19, in which case must be ≥ 19 years of age); 3. able and willing to provide written informed consent for this sub-study; 4. able and willing to comply with all study procedures; 5. able to read and speak english. phone application 1. have a personal google user account or be willing to create and own a personal google user account; 2. owns a personal android smartphone with a data plan and is the sole user of that smartphone; 3. agrees to download and maintain the phone application onto personal android smartphone for the duration of the sub-study; study watch 1. willing to comply with study watch wearing and recharging requirements exclusion criteria: all subjects 1. any condition or situation the principal investigator determines as inappropriate for study inclusion phone application no additional exclusion criteria for phone application study watch 1. subjects with known severe allergy to nickel or metal jewelry

Keywords: depression trd
interest of continuous ropivacaine administration through an elastomeric pump (pain buster) for the surgery of latissimus dorsi and serratus micro anastomotic flaps

Conditions: Post Operative Analgesia

Summary: continuous bupivacaine administration through an elastomeric pump (pain buster) has been found effective for post operative analgesia in a large range of surgery. ropivacaine is a less toxic drug, never tested in the surgery of latissimus dorsi and serratus micro anastomotic flaps (from the investigators knowledge). the aim of the study is to evaluate the usefulness of this drug and device for post operative analgesia, associated with patient controlled analgesia with morphine. for this purpose a controlled randomized double blind trial against placebo (saline) is performed, enrolling 40 (20x2) patients during 3 years, in order to measure total morphine consumption during the first 48 post operative hours and to evaluate analgesia and sides effects of morphine in each group.


Eligibility criteria:
inclusion criteria: * operated for latissimus dorsi and serratus micro anastomotic flaps. * 18 to 75 years old * asa i-ii * hospitalized in nantes chu burns icu * giving their written informed consent * with healthcare protection exclusion criteria: * declining the study * with known sides effects with morphine and local anesthetics * with known allergy or other reaction with used drugs * with disease incompatible with anaesthetic procedure * under law protection * taking antiepileptic or antidepressant drugs * pregnant (not any gender criteria)

Keywords: ropivacaine elastomeric pump patient controlled analgesia morphine consumption
node and atrial fibrillation ablation for persistent atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: the purpose of the study is to assess combining af ablation, with av node ablation and pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial fibrillation. the study will last 13 months.


Eligibility criteria:
inclusion criteria: * patients with symptomatic drug refractory atrial fibrillation. * patients who have had pacemaker implantation and av node ablation with ongoing symptoms. * patients will already be refractory to at least 2 rate or rhythm control drugs. * patients must be over 18 years old. * patients give informed consent form prior to participating in this study. exclusion criteria: * patient is suffering with unstable angina in last 1 week. * patient has had a myocardial infarction within last 2 months. * patient is expecting or has had major cardiac surgery within last 2 months. * patient is participating in a conflicting study. * patient is unable to perform exercise testing. * patient is mentally incapacitated and cannot consent or comply with follow-up. * patient has nyha class iii/ iv heart failure. * patient has lvef \<35% not secondary to tachycardia. * pregnancy. * patient suffers with other cardiac rhythm disorders. * recent coronary artery intervention or other factors suggesting clinical instability (ecg, clinical or laboratory findings).

Keywords: atrial fibrillation ablation
assessment of central sensitization, neuropathic pain, sleep quality and daily life activities in behcet's disease

Conditions: Behcet's Disease; Central Sensitisation

Summary: there are few studies in the literature regarding increased frequency of neuropathic pain and sleep disturbance and decreased quality of life in behçet's disease. frequency of central sensitization was not investigated in patients with behçet's disease before. in this study, it is aimed to investigate the frequency of central sensitization, neuropathic pain, sleep disorder and quality of life and their relation to each other in behcet's disease.

central sensitization reduces the pain threshold in the pain pathways of the nervous system, causing pain sensation to be perceived with lower stimuli and often causing chronic pain. central sensitization can be seen with many conditions such as neuropathic pain and sleep disorders, as well as with inflammatory diseases such as rheumatoid arthritis. there are few studies in the literature regarding increased frequency of neuropathic pain and sleep disturbance and decreased quality of life in behçet's disease. frequency of central sensitization was not investigated in patients with behçet's disease before. in this study, it is aimed to investigate the frequency of central sensitization, neuropathic pain, sleep disorder and quality of life and their relation to each other in patients with behcet's disease and healthy controls.

Eligibility criteria:
inclusion criteria: * patients diagnosed with behcet disease according to international study group criteria * healthy volunteers without previously known systemic chronic disease * patients older than 18 * patients younger than 75 exclusion criteria: * participants which were previously diagnosed with diabetes mellitus * participants which were previously diagnosed with chronic renal failure * pregnant women

Keywords: behcet's disease central sensitisation neuropathic pain sleep disturbance